ES2708673T3 - Synthetic coating and production procedure - Google Patents

Abstract

Plastic coating for a thermal tray (4), comprising a zone of the tank (1) adaptable to the shape of the tank (4) and a zone of the skirt (2) which is connected to the zone of the tank (1) ) to cover the lower structure of the tank (4), where the zone of the tank (1) comprises an area of the side wall (11) to cover the side wall of the tank (4) and a zone of the base ( 3) to cover the base of the tank (4), characterized in that the zone of the falcon (2) comprises polyethylene, and the zone of the side wall (11) comprises at least polyamide and polyethylene, and the zone of the base (3). ) comprises at least one fluoropolymer, particularly tetrafluoroethylene-hexafluoropropylene copolymer (FEP) or polytetrafluoroethylene (PTFE). and because the zone of the side wall (11) and the zone of the base (3) are designed as flexible and transparent sheets.

Description

DESCRIPTION

Synthetic coating and production procedure

The invention relates to a plastic coating for a thermal tray, comprising an area of the tray adaptable to the shape of the tray and a skirt area attached to the tray area to cover a bottom structure of the tray. The invention also relates to a process for producing said plastic coating.

Said plastic coatings are known according to the state of the art for their application in surgical operations. Instead of cleaning and disinfecting the cuvette after each operation, the tray area of the sterile plastic cover is inserted into the cuvette, the skirt area is folded over the lower structure of the cuvette and the necessary liquid, for example a solution sterile saline, is poured in the area of the bucket. The plastic coating can be discarded after use.

The buckets used in operations are as a rule of metal and have a heated base to preheat the liquid to body temperature. In this respect the problem arises that the plastic coating comes into contact with the heated base of the metal tray and is damaged. Also, the practice has shown that the plastic coating in the area of the bucket must withstand high mechanical stresses, for example, exerted by surgical instruments.

In EP 2524665 A1 it is suggested to solve this problem a plastic coating style for a heated tray, in which the plastic coating is multilayer in the area of the tank and also has an aluminum section as thermal insulation layer. The multiple layers in the area of the tank ensure the sealing of the coating even in case of mechanical damage to the inner layer. The aluminum section serves as a thermal insulation layer to protect the plastic against temperature peaks.

However, this plastic coating has some disadvantages. The multiple layers in the zone of the tray inevitably involve non-uniform transmission of thermal energy from the metal tray to the liquid to be heated, since gaps or insulating folds can be formed between the individual layers of the coating. Furthermore, the aluminum section is not transparent, so that the user can not check the condition of the tray itself, nor whether the coating in the area of the tray is directly in contact with the heated tray. There may be folds or foreign particles between the aluminum section and the metal tray that can not be seen from outside. Furthermore, due to the high thermal conductivity of the aluminum section it is inevitable that the temperature peaks are transmitted particularly well to the inner layer of the plastic coating, so that the aluminum section only performs its task of thermal insulation poorly.

In EP 2 524 665 A1, US 5,457,962 A and DE 698 30 725 T2, among other documents, conventional plastic coatings are disclosed. The objective task of the invention is, therefore, to eliminate this and other disadvantages of conventional plastic coatings. This is achieved by a plastic coating according to claim 1, as well as by a method for the production of a plastic coating according to the invention according to claim 10. The plastic coating according to the invention comprises an area of the skirt, which comprises polyethylene or is designed as a polyethylene sheet. The area of the bowl attached to the skirt area comprises an area of the side wall to cover the side wall of the bowl, as well as a base area to cover the base of the bowl. The zone of the side wall contains at least polyamide and polyethylene and is especially designed in the form of a laminate of a combination of polyamide and polyethylene.

According to the invention, the zone of the base contains at least one heat-resistant fluoropolymer, particularly tetrafluoroethylene-hexafluoropropylene copolymer (FEP) or polytetrafluoroethylene (PTFE).

The zone of the side wall and the zone of the base are designed as transparent and flexible sheets to allow the plastic coating to adapt to the shape of the tray.

Since the base comprises a fluoropolymer, in particular a copolymer of tetrafluoroethylenehexafluoropropylene (FEP) or polytetrafluoroethylene (PTFE), a high heat resistance of the plastic coating in the area of the base is ensured.

According to the invention, the zone of the base can be preferably conceived as a thermal combination of an FEP or PTFE sheet with another plastic, for example polyethylene. In this case, according to the invention it can be foreseen that the FEP or PTFE sheet is disposed on each side of the area of the base that comes into contact with the heated tray during its use.

According to the invention it can be envisaged that the area of the side wall, the zone of the base and the area of the skirt of the plastic coating are monolayer. In this way the occurrence between individual layers of voids or foreign bodies that can compromise the optimal thermal conductivity to the liquid that is desired to heat is avoided.

According to the invention it can be foreseen that the skirt area has a thickness in the range of 40pm to 80pm, preferably 60pm.

According to the invention it can be envisaged that the zone of the side wall has a thickness in the range from 120pm to 180pm, preferably 150pm.

According to the invention, it can be envisaged that the base region has a thickness in the range of 200 to 300 ppm, preferably 260 ppm.

Since the area of the base is thicker than the area of the side wall, and that the area of the side wall is thicker than the area of the skirt, thus ensuring that the area of the side wall and, particularly, the The base area offers sufficient stability against mechanical stresses due to the deposit of surgical instruments, while the entire plastic coating remains light and compact, so that it can be stored in a standard sterile package.

The area of the base can be of a particularly circular shape with a diameter of 20cm to 30cm, preferably of approximately 26cm. The area of the side wall attached to the base area can have a height or extension of 5cm to 15cm, preferably of approximately 7cm, and extend cylindrically or conically outwards. Finally, the skirt area can have an essentially larger extension, for example from 50cm to 100cm, preferably approximately 75cm, and preferably also extend concomitantly to facilitate its folding over the edge of the tray.

According to the invention it can be envisaged that the area of the trough that folds in the area of the skirt will be joined to the skirt area, particularly by means of a perimeter thermal welding cord.

According to the invention it can be envisaged that the zone of the side wall comprises a combination of polyamide with a polyethylene seal on both sides. The area of the side wall can be made in particular of NICE XX8 material from the company WIPAK or comprise this material.

According to the invention it can be provided that the base area, the side wall area and the skirt area are at least partially transparent or translucent.

The invention also encompasses a process for the production of a plastic coating according to the invention, wherein a first layer comprising a sheet of a fluoropolymer, particularly a tetrafluoroethylene copolymer, is first pasted for the production of the base zone. hexafluoropropylene (FEP) or polytetrafluoroethylene (PTFE) with a second layer of polyethylene with medical adhesive and this combination is welded thermally and over the entire surface with a third layer in a second stage. The third layer can preferably be the area of the side wall, so that the area of the base is joined to the whole area of the side wall by the welding process. However, the third layer can also be another layer that is joined to the side wall region or joined in another stage of the process. In another process step, the area of the side wall is connected to the skirt area, preferably by means of a perimetral weld bead.

According to the invention it can be foreseen that for the production of the zone of the base the first layer used has a thickness of 20pm to 40pm, preferably of 30pm, and that the second layer has a thickness of 60pm to 100pm, preferably 80pm .

From the claims, the description of the exemplary embodiments and the figures show other characteristics according to the invention. In the following, the invention will be detailed from an example of non-limiting embodiment.

Figure 1a shows an embodiment of a plastic coating according to the invention. The plastic coating is essentially bag-shaped and comprises an area of the tray 1 and a zone of the skirt 2 that extends conically, both of which are connected along a perimeter thermal weld cord. To use the plastic coating, the area of the tray 1 is inserted into the tray 4 and the skirt area is folded over the upper opening of the tray 4 so that the skirt area covers the lower structure of the tray. To this end, the zone of the tray 1 is adapted or can be adapted to the shape of the tray 4 and the area of the skirt 2 has a stretchable portion to facilitate folding. The zone of the skirt 2 is formed by a conventional transparent polyethylene sheet with a thickness of about 60pm.

The area of the basin 1 is divided into an area of the base 3 essentially flat for direct contact with the base heated from the bowl 4 and in an area of the conical extension side wall 11 in the present exemplary embodiment for covering the side wall of the cover 4.

The area of the side wall 11 is designed as a sheet comprising at least polyamide and polyethylene. In the present exemplary embodiment, the zone of the side wall 11 has a thickness of approximately 150pm. In a preferred embodiment of the invention, the area of the side wall 11 is made of a NICE XX8 material from the company WIPAK. The NICE material XX8 may particularly comprise a combination of polyamide with a polyethylene seal on both sides.

The zone of the base 3 is conceived as a flexible and transparent or at least translucent sheet and comprises a heat resistant fluoropolymer. The fluoropolymer is preferably located on an outer face of the area of the base 3, that is, on the face which, after insertion in the tray 4, comes in direct contact with the base of the tray 4. For this purpose, the thermal resistance of the material of fluoropolymer in the hot base of the cuvette should be sufficient for this face of the zone of the base 3 to function as a thermal insulation layer.

In an exemplary embodiment, the fluoropolymer can be a tetrafluoroethylene hexafluoropropylene copolymer (FEP). In another embodiment, the fluoropolymer can be polytetrafluoroethylene (PTFE, Teflon).

In fig. 1a shows a detail of the production process according to the invention of the plastic coating according to the invention. In the production of the plastic coating, a first layer 8 comprising a fluoropolymer sheet, particularly a tetrafluoroethylene-hexafluoropropylene copolymer (FEP) or polytetrafluoroethylene (PTFE) with a second layer, is pasted in the production of the plastic coating for the production of the zone 3. 9 polyethylene with medical adhesive 10 over the entire surface.

In a second step this combination is thermally welded over the entire surface with third layer 7. In the embodiment shown, the third layer 7 is identical to the sheet in the area of the side wall 11. In other embodiments, the third layer layer 7 can be a separate sheet attached to the area of the side wall 11.

This thermal welding of the individual faces in the area of the base 3 serves so that the area of the base 3 of the plastic coating according to the invention forms a single layer having both the necessary mechanical resistance and, in the area that enters in contact with the cuvette, the resistance to high temperatures needed. Thus, the area of the resulting base 3 is fine enough to guarantee adequate thermal conductivity.

In the present exemplary embodiment the first layer 8 has a thickness of about 30pm, the second layer 9 a thickness of about 80pm and the third layer 7 a thickness of about 150pm, so that the total thickness of the resulting sheet in the area from base 3 is approximately 260pm. This, on the one hand, is thick enough to guarantee good stability against mechanical stress and, on the other hand, it is sufficiently thin to conduct enough heat from the heated tray 4 to the liquid to be heated. Figure 1b shows a section of a plastic coating according to the invention that is inserted in a trough 4. In the area of the base 3, the fact that the layers indicated above are thermally welded together over the entire surface is highlighted so that the zone of the base is monolayer and, with it, a continuous transition from the base of the tank 4 to the liquid to be heated. The area of the side wall 11 is adapted to the shape of the side wall of the tank 4. To this end, the area of the side wall 11 extends flexibly and lightly outwardly. The area of the skirt 2 is joined by a perimeter weld cord 5 to the area of the side wall 11 and, in the state shown, is folded down over the edge of the tank 4 to cover the lower structure of the bucket. The zone of the base 3, the zone of the side wall 11 and the zone of the skirt 2 are transparent or at least translucent to provide the user with control over the coating and the condition of the underlying tray 4.

The invention is not limited to the purpose of the plastic coating represented in the medical field, but also comprises the use of plastic coatings according to the invention for other applications.

Claims (11)

1. Plastic coating for a thermal tray (4), comprising a zone of the tank (1) adaptable to the shape of the tank (4) and a zone of the skirt (2) that is attached to the area of the tank (1) to cover the lower structure of the tank (4), where the area of the tank (1) comprises an area of the side wall (11) to cover the side wall of the tank (4) and an area of the tank (4). base (3) to cover the base of the tray (4), characterized in that the zone of the falcon (2) comprises polyethylene, and the zone of the side wall (11) comprises at least polyamide and polyethylene, and the zone of the base (3) comprises at least one fluoropolymer, particularly tetrafluoroethylenehexafluoropropylene copolymer (FEP) or polytetrafluoroethylene (PTFE). and because the zone of the side wall (11) and the zone of the base (3) are designed as flexible and transparent sheets. 2. Plastic coating according to claim 1, characterized in that the zone of the side wall (11), the zone of the base (3) and the zone of the skirt (2) are monolayer. 3. Plastic coating according to claim 1 or 2, characterized in that the area of the base (3) has a thickness greater than the area of the side wall (11), and the area of the side wall (11) presents a thickness greater than the area of the skirt (2). Plastic coating according to any of claims 1 to 3, characterized in that the zone of the skirt (2) has a thickness in the range of 40pm to 80pm, preferably 60pm. Plastic coating according to any of claims 1 to 4, characterized in that the zone of the side wall (11) has a thickness in the range of 120pm to 180pm, preferably 150pm. Plastic coating according to any of claims 1 to 5, characterized in that the zone of the base (3) has a thickness in the range of 200pm to 300pm, preferably 260pm. Plastic coating according to any one of claims 1 to 6, characterized in that the area of the tray (1) which is folded in the area of the skirt (2) is connected in particular by means of a heat sealing cord (5). ). Plastic coating according to any of claims 1 to 7, characterized in that the zone of the side wall (11) comprises a combination of polyamide with a polyethylene seal on both sides. 9. Plastic coating according to any of claims 1 to 8, characterized in that the zone of the base (3), the area of the side wall (11) and the area of the skirt (2) is at least partially transparent. 10. Process for the production of a plastic coating according to any of claims 1 to 9, characterized in that a first layer (8) comprising a sheet of a fluoropolymer is stuck to produce the zone of the base (3), particularly tetrafluoroethylenehexafluoropropylene copolymer (FEP) or polytetrafluoroethylene (PTFE), with a second layer (9) of polyethylene by means of medical adhesive (10), and this combination is thermally welded over the entire surface with a third layer (7), where the third layer (7) forms a unit together with the sheet in the area of the side wall (11) or comprises it, and where the area of the side wall (11) and the base area (3) are designed as flexible and transparent sheets. 11. Process for the production of a plastic coating according to claim 10, characterized in that the first layer (8) has a thickness of 20pm to 40pm, preferably 30pm, and the second layer (9) has a thickness of 60pm at 100pm, preferably at 80pm